Ifirmasta 75 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Ifirmasta 75 mg film-coated tablets EFG

Irbesartan

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• • This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Ifirmasta is and what it is used for
2. What you need to know before taking Ifirmasta
3. How to take Ifirmasta
4. Possible side effects
5. How to store Ifirmasta
6. Contents of the pack and other information

1. What Ifirmasta is and what it is used for

Ifirmasta belongs to a group of medicines known as angiotensin-II receptor antagonists.

Angiotensin-II is a substance produced in the body that binds to receptors, causing blood vessels to constrict. This results in an increase in blood pressure. Ifirmasta prevents angiotensin-II from binding to these receptors, relaxing the blood vessels and thereby reducing blood pressure.

Ifirmasta slows down the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.

Ifirmasta is used in adult patients

• to treat high blood pressure (essential hypertension)
• to protect the kidneys in patients with high blood pressure, type 2 diabetes, and clinical evidence of impaired kidney function.

2. What you need to know before taking Ifirmasta

Do not take Ifirmasta

• if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6),
• • if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section),
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Ifirmasta and if any of the

following apply to you:

• if you have excessive vomiting or diarrhoea

• if you have kidney problems

• if you have heart problems

• • if you are taking Ifirmasta for diabetic kidney disease. In this case, your doctor may carry out regular blood tests, especially to measure potassium levels in case of impaired kidney function

• if you are going to have surgery or will be given anaesthetics

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,

• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (for example, potassium) at regular intervals.

See also the information under the heading “Do not take Ifirmasta”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of Ifirmasta is not recommended during early pregnancy (first three months), and in no case should it be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby (see Pregnancy section).

Children and adolescents

This medicine should not be used in children and adolescents (< 18 years) as safety and efficacy have not yet been fully established.

Taking Ifirmasta with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Ifirmasta” and “Warnings and precautions”).

You may need to have blood tests if you are taking:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines (such as certain diuretics)
• medicines containing lithium.

If you are taking a type of painkiller known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking Ifirmasta before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive treatment. The use of Ifirmasta is not recommended during early pregnancy, and in no case should it be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding, as Ifirmasta is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable for you if you intend to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

It is unlikely that Ifirmasta will affect your ability to drive or use machines. However, during treatment for hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, discuss them with your doctor before driving or operating machinery.

3. How to take Ifirmasta

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Method of administration

Ifirmasta is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Ifirmasta may be taken with or without food. You should try to take your daily dose at the same time each day. It is important that you continue taking this medicine until your doctor advises you otherwise.

• Patients with high blood pressure

The usual dose is 150 mg once daily (two tablets per day). Subsequently, and depending on the blood pressure response, this dose may be increased to 300 mg once daily (four tablets per day).

• Patients with high blood pressure and type 2 diabetes with kidney impairment

In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for treatment of associated kidney impairment is 300 mg once daily (four tablets per day).

Your doctor may recommend a lower dose, especially at the beginning of treatment, in certain patients, such as haemodialysis patients or patients over 75 years of age.

Maximum blood pressure-lowering effect should be achieved within 4–6 weeks after starting treatment.

Use in children and adolescents

Ifirmasta must not be given to children under 18 years of age. If a child swallows several tablets, contact your doctor immediately.

If you take more Ifirmasta than you should

If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Ifirmasta

If you accidentally miss a dose, simply take your next dose at the usual time. Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some of these adverse effects can be serious and may require immediate medical attention.

As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you think you may be experiencing such a reaction or have difficulty breathing, stop taking Ifirmasta and seek immediate medical attention.

The adverse effects listed below are grouped according to their frequency as follows:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Adverse effects reported in clinical trials conducted in patients treated with Ifirmasta were:

• Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show increased levels of potassium.
• Common (may affect up to 1 in 10 people): dizziness, nausea/vomiting, fatigue, and blood tests may show elevated levels of an enzyme measuring muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney impairment: dizziness (especially upon standing), low blood pressure (especially upon standing), muscle or joint pain, and decreased levels of a protein present in red blood cells (haemoglobin).
• Uncommon (may affect up to 1 in 100 people): tachycardia, skin redness, cough, diarrhoea, indigestion/acid reflux, sexual dysfunction (disturbances in sexual function), and chest pain.

Since the marketing of Ifirmasta, additional adverse effects have been reported. Adverse effects observed with unknown frequency include: vertigo, headache, taste disturbances, tinnitus, muscle cramps, muscle and joint pain, reduced platelet count, abnormal liver function, increased blood potassium levels, kidney function impairment, inflammation of small blood vessels, mainly in the skin (a condition known as leukocytoclastic vasculitis), and severe allergic reactions (anaphylactic shock). Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ifirmasta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unwanted medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ifirmasta

• The active substance is irbesartan. Each film-coated tablet contains 75 mg of irbesartan (as hydrochloride).

The other components are: in the tablet core: mannitol, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose (LH-21), low-substituted hydroxypropyl cellulose (LH-11), talc, macrogol 6000 and hydrogenated castor oil; in the film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 and talc.

Appearance of the product and contents of the pack

Ifirmasta 75 mg film-coated tablets are white and oval-shaped.

Ifirmasta 75 mg film-coated tablets are available in boxes, in blisters of 14, 28, 30, 56, 84, 90 and 98 tablets, and in boxes of 56 x 1 film-coated tablets in pre-cut single-dose blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarjeska cesta 6, 8501 Novo mesto, Slovenia

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent revision of this leaflet: {Month/Year}.

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.